The following data is part of a premarket notification filed by Captiva Spine with the FDA for Caplox Ii/towerlox Pedicle Screw System.
| Device ID | K151116 |
| 510k Number | K151116 |
| Device Name: | CapLOX II/TowerLOX Pedicle Screw System |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | CAPTIVA SPINE 967 ALTERNATE A1A #1 Jupiter, FL 33477 |
| Contact | Tamala Wampler |
| Correspondent | Kenneth C. Maxwell EMPIRICAL TESTING CORPORATION 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-27 |
| Decision Date | 2015-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M73924714963 | K151116 | 000 |